MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRIO MESH; SURGICAL MESH

Catalog Number	0010211
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Hernia (2240)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Attorney alleges that the plaintiff underwent incisional hernia repair surgery and was implanted with bard/davol ventralex on (b)(6) 2010.It is alleged that the patient suffered the development of hernia recurrence, adhesions and chronic pain.It is also alleged that the patient underwent a corrective revision surgery on or about (b)(6) 2013 and was implanted with bard/davol ventrio.It is alleged that the plaintiff "has suffered injuries, losses, and damages resulting from numerous defects in the product that create an unreasonably high risk of injury with severe permanent adverse health consequences." attorney alleges the plaintiff suffered permanent injuries including scarring, disfigurement." attorney alleges the plaintiff's adverse reaction, complications, and further surgery directly and proximately resulted from the defective and dangerous condition of the product"; the plaintiff sustained injuries including hernia recurrence, mesh adhesions, chronic pain and permanent physical disability due to the product.It is alleged that the plaintiff continues to undergo medical care and treatment.It is also alleged that the patient sustained personal injury and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, hernia recurrence, adhesions and pain.The instructions-for-use (ifu) supplied with the device lists hernia recurrence and adhesions as a possible complications.Note, the date of event is provided as a best estimate (b)(6) 2022 based on the date of awareness.This mdr represents the bard/davol ventrio mesh (device #2).An additional mdr was submitted to represent the bard/davol mesh ¿ ventralex (device #1).Should additional information be provided, a supplemental mdr will be submitted.Not returned.

• Brand Name: VENTRIO MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 15812853
• Report Number: 1213643-2022-00742
• Device Sequence Number: 14784489
• Product Code: FTL
• UDI-Device Identifier: 00801741016387
• UDI-Public: (01)00801741016387
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2014
• Device Catalogue Number: 0010211
• Device Lot Number: HUVH0737
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Male